A Phase 3 Study To Compare The Efficacy And Safety Of 0.3 MG Pegaptanib Sodium To Sham Injections In Subjects With Diabetic Macular Edema

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Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 54: Open Phase [ Time Frame: Baseline and Week 54 ]

Number of Participants Exhibiting a Decrease From Baseline in Retinal Thickness at the Center Point by ≥25 Percent and ≥50 Percent Using Optical Coherence Tomography (OCT) at Week 24: Double Masked Phase [ Time Frame: Baseline and Week 24 ]

OCT, a noninvasive, noncontact, transpupillary imaging technology, was utilized to image retinal structures in vivo. The anatomic layers within the retina, retinal thickness could be measured.

NEI-VFQ 25, Japanese version v.1.4 for self-administering questionnaires consisted of the base set of 25 questions and 12 subscale scores.

Response categories to each question were converted to a 0 to 100 scale so that the lowest and highest possible scores were set at 0 and 100 points, respectively. A higher score represented better functioning. Questions within each sub-scale were averaged together to create the 12 sub-scale scores. The overall composite score was calculated by averaging the vision-targeted subscale scores excluding the general health-rating question.

Positive change indicated improvement.

Mean Visual Acuity Over Time at Each Time Point: Open Phase [ Time Frame: Baseline, Weeks 30, 36, 42, 48, and 54 ]

Number of Participants Who Experience a ≥15, ≥5, or ≥0 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 54: Open Phase [ Time Frame: Baseline and Week 54 ]

Number of Participants Exhibiting a Decrease From Baseline in Retinal Thickness at the Center Point by ≥25 Percent and ≥50 Percent Using Optical Coherence Tomography (OCT) at Week 54: Open Phase [ Time Frame: Baseline and Week 54 ]

NEI-VFQ 25, Japanese version v.1.4 for self-administering questionnaires consisted of the base set of 25 questions and 12 subscale scores.

Response categories to each question were converted to a 0 to 100 scale so that the lowest and highest possible scores were set at 0 and 100 points, respectively. A higher score represented better functioning. Questions within each sub-scale were averaged together to create the 12 sub-scale scores. The overall composite score was calculated by averaging the vision-targeted subscale scores excluding the general health-rating question.

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Ages Eligible for Study:

20 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Type I, or Type II diabetic subjects

Subjects must have macular edema that involves the center field of the macula 3. Foveal thickness of at least 250 μm 4. Best corrected distance visual acuity in the study eye must be a letter score between 68 and 35 inclusive

Exclusion Criteria:

Eyes with prior panretinal photocoagulation (PRP) less than 4 months prior to baseline eyes in which PRP is needed now or is likely to be needed within the next 9 months

HbA1C level >12% or recent signs of uncontrolled diabetes

Atrophy/scarring/fibrosis involving the center of the macula, including evidence of laser treated atrophy